NDC 36987-3257

Rough Marsh Elder

Rough Marsh Elder

Rough Marsh Elder is a Intradermal; Subcutaneous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Nelco Laboratories, Inc.. The primary component is Iva Annua Var. Annua Pollen.

Product ID36987-3257_39113b10-fd1f-4cfc-8432-755a1686fcc4
NDC36987-3257
Product TypeHuman Prescription Drug
Proprietary NameRough Marsh Elder
Generic NameRough Marsh Elder
Dosage FormInjection, Solution
Route of AdministrationINTRADERMAL; SUBCUTANEOUS
Marketing Start Date1972-08-29
Marketing CategoryBLA / BLA
Application NumberBLA102192
Labeler NameNelco Laboratories, Inc.
Substance NameIVA ANNUA VAR. ANNUA POLLEN
Active Ingredient Strength40000 [PNU]/mL
Pharm ClassesNon-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS]
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 36987-3257-2

10 mL in 1 VIAL, MULTI-DOSE (36987-3257-2)
Marketing Start Date1972-08-29
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 36987-3257-2 [36987325702]

Rough Marsh Elder INJECTION, SOLUTION
Marketing CategoryBLA
Application NumberBLA102192
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date1972-08-29
Inactivation Date2019-10-21

NDC 36987-3257-1 [36987325701]

Rough Marsh Elder INJECTION, SOLUTION
Marketing CategoryBLA
Application NumberBLA102192
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date1972-08-29
Inactivation Date2019-10-21

NDC 36987-3257-3 [36987325703]

Rough Marsh Elder INJECTION, SOLUTION
Marketing CategoryBLA
Application NumberBLA102192
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date1972-08-29
Inactivation Date2019-10-21

NDC 36987-3257-4 [36987325704]

Rough Marsh Elder INJECTION, SOLUTION
Marketing CategoryBLA
Application NumberBLA102192
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date1972-08-29
Inactivation Date2019-10-21

Drug Details

Active Ingredients

IngredientStrength
IVA ANNUA VAR. ANNUA POLLEN40000 [PNU]/mL

OpenFDA Data

SPL SET ID:a63e5aef-44c2-4f90-a33d-91ec10298089
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 897968
  • 896133
  • 897315
  • 896281
  • 1006367
  • 895914
  • 895614
  • 896290
  • 1006488
  • 895679
  • 896265
  • 897977
  • 896302
  • 896080
  • 897402
  • 1013974
  • 897959
  • 897951
  • 896198
  • 897998
  • 901477
  • 896173
  • 896158
  • 1006359
  • 897376
  • 897327
  • 1013976
  • 896211
  • 895728
  • 897343
  • 897533
  • 898339
  • 896114
  • 896257
  • 901495
  • 897384
  • 1013991
  • Pharmacological Class

    • Non-Standardized Pollen Allergenic Extract [EPC]
    • Increased Histamine Release [PE]
    • Cell-mediated Immunity [PE]
    • Increased IgG Production [PE]
    • Pollen [CS]
    • Allergens [CS]

    NDC Crossover Matching brand name "Rough Marsh Elder" or generic name "Rough Marsh Elder"

    NDCBrand NameGeneric Name
    36987-3253Rough Marsh ElderRough Marsh Elder
    36987-3254Rough Marsh ElderRough Marsh Elder
    36987-3255Rough Marsh ElderRough Marsh Elder
    36987-3256Rough Marsh ElderRough Marsh Elder
    36987-3257Rough Marsh ElderRough Marsh Elder
    36987-3258Rough Marsh ElderRough Marsh Elder
    36987-3259Rough Marsh ElderRough Marsh Elder
    36987-3260Rough Marsh ElderRough Marsh Elder
    49288-0270Rough Marsh ElderRough Marsh Elder
    49288-0271Rough Marsh ElderRough Marsh Elder

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